FAQ About Sanjana Gaddam

• What is Sanjana Gaddam's address?

  Sanjana Gaddam is located at
  Raleigh-Durham-Chapel Hill Area, Raleigh-Durham-Chapel Hill Area, United States

• What is Sanjana Gaddam's job title?

  Sanjana Gaddam is a • Experience in providing computer validation direction and oversight to project teams by giving guidance on computer validation requirements and by reviewing validation deliverables to ensure compliance with FDA regulations. • Strong knowledge about pharmaceutical/medical device regulations like FDA: 21 CFR Part 210, Part 211 and Part 820 and involved in implementation of CFR Part 11 rules (Electronic Records, Electronic Signatures and Audit Trails). • Excellent working knowledge and grasp of Data Integrity guidelines – FDA’s GMP Data Integrity definitions, guidelines including ALCOA framework (Attributable, Legible, Contemporaneous, Original and Accurate); and ALOCA + (Complete, Consistent, Enduring, Available). • Expertise in drafting, reviewing and approving SDLC deliverables; Validation Plan (VP), Requirement Specification (RS), Design Specification (DS), Configuration Specification (CS), User Requirement Specification (URS), Test Plan (TP), Requirement Traceability Matrix (RTM); Test Protocols – Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ); Test Summary Report; Vendor Audit Reports; Gap Analysis and Risk Assessment Reports, SOPs and Policies. • Thorough knowledge supporting compliance to Good Documentation Practices (GDP) during assigned document reviews. • Participated in User Acceptance Testing (UAT); reviewed and approved System Integration Testing (SIT), Release Management and Technical Documentation spanning the full cycle of product development. • Good understanding on Change Management process and implemented TrackWise for managing Change Mechanism. • Outstanding experience in using HP ALM (Requirements, Test Lab, Test Plan, Defects & Dashboard modules) for reviewing and approving, testing and defects management. • Experience in performing Gap Analysis and reviewing Corrective and Preventive Actions (CAPA) and suggesting the Remediation Plans to mitigate the non-compliance.

• What industry does Sanjana Gaddam currently work in?

  Sanjana Gaddam currently works in the Grail |

• Which languages does Sanjana Gaddam speak?

  No Languages Available

• Which industries has Sanjana Gaddam previously worked in?

  Sanjana Gaddam has prior
  experience in the following industries:
  Merck | Biogen | Edwards Lifesciences | Bharat Biotech International

• What is Sanjana Gaddam’s work experience?

  Sanjana Gaddam has the following professional experience:
  Grail | Merck | Biogen | Edwards Lifesciences | Bharat Biotech International

• How can I find Sanjana Gaddam on LinkedIn?

  You can view Sanjana Gaddam’s LinkedIn profile at LinkedIn URL

• What are Sanjana Gaddam’s work email addresses?

  Sanjana Gaddam’s work email
  addresses are
  sanjana.gaddam@merck.com

• What company does Sanjana Gaddam work for?

  Grail |